Accuracy of Needle Placement Into The Subacromial Space of The Shoulder
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Purpose
This study attempts to determine the most accurate route for injection of the subacromial bursa in patients with rotator cuff tendonitis. Typically, in medical practice, one of the routes of injection is used. It has not been determined if one route is superior, or if all routes are equal in delivering medication into the subacromial bursa, which sits on top of the rotator cuff tendons.
| Condition | Intervention |
|---|---|
|
Rotator Cuff Tendonitis |
Procedure: Injection of Subacromial Bursa |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Accuracy of Needle Placement Into The Subacromial Space of The Shoulder |
- Radiographic e Radiographic Evidence of Successful Subacromial Injection [ Time Frame: One-hour post injection ] [ Designated as safety issue: No ]After injection of the subacromial bursa, all patients had two view radiographs performed within one hour to assess the accuracy of the injections
| Enrollment: | 75 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Anterior injection Route
Group of patients injected with medication using the anterior route
|
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain
|
|
Active Comparator: Posterior Injection
Group of patients receiving injection through a posterior route
|
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain
|
|
Active Comparator: Lateral Injection
Group of patients receiving subacromial injection through a lateral route
|
Procedure: Injection of Subacromial Bursa
Injection of steroid and anesthetic to relieve pain
|
Detailed Description:
Patients with a diagnosis of rotator cuff tendonitis, having failed other non-operative measures, are offered an injection of steroid and local anesthetic to relieve their pain. This is standard treatment. In this study, patients are prospectively randomized to receive their injection by one of the three commonly used routes: anterior, posterior, or lateral. Accuracy of the injection is determined by including a small amount of contrast dye in the injection which will make the injection visible on post-injection radiographs.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- rotator cuff tendinitis
Exclusion Criteria:
- diabetes
- allergy to contrast dye
- renal disease
- pregnancy
- frozen shoulder
Contacts and Locations| United States, California | |
| University of California, Davis Department of Orthopaedic Surgery | |
| Sacramento, California, United States, 95817 | |
| Principal Investigator: | Richard A Marder, MD | University of California, Davis |
More Information
No publications provided
| Responsible Party: | Richard A. Marder MD, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT01330641 History of Changes |
| Other Study ID Numbers: | 200816140 |
| Study First Received: | April 5, 2011 |
| Last Updated: | April 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Davis:
|
Tendonitis Rotator Cuff Shoulder Injection |
Additional relevant MeSH terms:
|
Tendinopathy Muscular Diseases Musculoskeletal Diseases Tendon Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013